The US Food and Drug Administration has warned physicians that it may be dangerous to use a device known as the Lariat to close the left atrial appendage in patients with heart arrhythmias.
The US Food and Drug Administration (FDA) has warned physicians that it may be dangerous to use a device known as the Lariat to close the left atrial appendage (LAA) in patients with heart arrhythmias.
The tool is currently approved to deliver sutures for soft tissue closure, but a number of physicians have been using it as an off-label aid for appendage closures that can prevent strokes in patients with atrial fibrillation (AF).
Early trial data support the practice, but the results of several other studies suggest that it might be dangerous. Such conclusion prompted FDA officials to perform an investigation of their own and summarize their findings in the alert.
“The FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database for reports of adverse events with the use of the Lariat Suture Delivery Device and its associated devices. We identified 45 adverse events through June 30, 2015 that occurred in patients undergoing LAA closure procedures with the Lariat Suture Delivery Device and/or its associated devices,” FDA officials warned.
“These reports describe 6 patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete LAA detachment from the heart, bleeding (hemorrhage), low blood pressure (hypotension), fluid collection around the heart (pericardial effusion), fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade), and fluid collection around the lung (pleural effusion). Of the 45 adverse events reported to the FDA, 34 (approximately 75%) resulted in the need to perform emergency heart surgery.”
The FDA document stops short of telling physicians to avoid using the Lariat for LAA closure. It does, however, warn them that the device has not been established as a safe and effective tool for the procedure and urges them to consider better-studied alternatives.
The warning comes just 2 months after the online publication of an analytical review in JAMA Internal Medicine that raised questions about using the Lariat for LAA closures.
“In the systematic review, 5 reports of Lariat device use in 309 participants were identified,” the review authors wrote. “Specific complications weighted for inverse of variance of individual studies were urgent need for cardiac surgery (2.3%; 7 of 309 procedures) and death (0.3%; 1 of 309 procedures). Procedural success was 90.3% (279 of 309 procedures).”
Just as that paper appeared, researchers at the Heart Rhythm Society’s annual meeting presented data on outcomes for 99 consecutive AF patients whose surgeons used the Lariat for LAA closure during endo-epicardial ligation.
Physicians used 2-D or 3-D transesophageal echocardiography (TEE) to detect leaks immediately after surgery and, again, after 6 and 12 months. The study team then looked for evidence of adverse events associated with those leaks.
The first round of scans found 5 small leaks (≤ 5mm) in 5 patients and no leaks in the remaining 93. (“Unfavorable anatomy” rendered 1 patient ineligible for the surgery.) The second round of scans found ongoing leaks in 2 of the 5 patients with initial leakage — the other 3 patients showed no signs of residual leaks — and 12 new leaks (8 small and 4 large) among the other 93 patients. The third round of scans found another 5 new leaks (4 small and 1 large).
Among the 22 patients who exhibited some degree of LAA leakage at some point after surgery, there was 1 stroke and 1 transient ischemic attack in patients with small leaks during the follow-up period.
Such results conflict with early trial results, which suggested the Lariat is a safe and effective tool for LAA closure.
A phase 3 trial that is scheduled to start soon should provide definitive information about the safety and efficacy of using the Lariat to close left atrial appendages. Several hundred patients with long-standing and persistent AF will undergo that procedure as an adjunct to standard catheter ablation.